Cleared Traditional

K102756 - SURECORE BIOPSY DEVICE

K102756 is an FDA 510(k) clearance for SURECORE BIOPSY DEVICE, manufactured by Chest Innovations, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 432-day FDA review.

K102756 · Chest Innovations, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
432d
Days
Class 2
Risk

K102756 is an FDA 510(k) clearance for the SURECORE BIOPSY DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Chest Innovations, Inc. (San Jose, US). The FDA issued a Cleared decision on November 29, 2011 after a review of 432 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Chest Innovations, Inc. devices

FDA 510(k) Submission Details - K102756

510(k) Number K102756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2010
Decision Date November 29, 2011
Days to Decision 432 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 130d · This submission: 432d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 174
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